Bad Bearings: THE DEVOLUTION OF HIP REPLACEMENT IN AMERICA

Transcription

1 Bad Bearings: THE DEVOLUTION OF HIP REPLACEMENT IN AMERICA Stephen S. Tower, M.D. Orthopedic Surgeon Affiliated Professor University of Alaska President of the Alaska Arthroplasty Initiative

2 D I S C L O Industry Legal Work No S U R E S Alaska Arthroplasty Initiative $50,000 Grant Providence Alaska Medical Center

3 Explant Analysis $1000

4 Marketing trumps science and value NICE Report Cemented MoP $6000 Cemented CoP $8000 Hybrid MoP $10000 Un-cemented MoP $12000 Un-cemented CoC $16000 MoM Resurfacing $10000 MoM THA $14000 Safety And Value

5 Hip Replacement Costs USA 12K 120K JAMA 2/2013 Retrospective Study $ 0.01 per implant Implant Registration $50 per implant Explant Analysis 1K Generic Parts 5K Revision surgery K Efficacy Safety And Value Cost, Un-Proven parts 15K Space Suits and Laminar flow 1K (increase infections 3X) Complexity, and Complications

6 Mayo Clinic first 2000 Charnley Hips Dr. Declan Nolan 1970 Failure rate 1% per year patients < 50 0% per year patients > 70 years

7 Dr. Declan Nolan 2011

8 Mayo first 2000 CLFA Twenty-five-Year Survivorship of Two Thousand Consecutive Primary Charnley Total Hip Replacements and Bernard F. Morrey, MD The Journal of Bone and Joint Surgery (American) 84: (2002) Daniel J. Berry, MD, W. Scott Harmsen, MS, Miguel E. Cabanela, MD

9 The Holy Grail of Hip Replacement Lasts Forever Instant recovery Pain free Stable No activity limits Not poison the patient

10 501 K Devices Antecedent Device Pre-Market Approved Devices

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12 5 Year Revision Rates Predicate Charnley THA 1970s 2-3% 510K Metal-on-Metal THA (ASR) 44% (22X) 510K Modular Neck THA MoP or CoP Rejuvenate 44% (22X) PMA Metal-on-Metal Resurfacing Conserve Plus 10% (5X) BHR 4% (2X)

13 4 million Americans at Risk: Unexpected Failure Mechanisms Periprosthetic Metallosis Hypercobaltemia Pseudotumors Cobaltism from Hip Replacements with Chrome-Cobalt Components

14 At-risk populations USA Ceramic-on-Metal Wear (1000s) Metal-on-Metal Wear (1,000,000) Taper Corrosion (3,000,000) Metallosis: Pseudotumors Hypercobaltemia: Cobaltism

15 Ceramic-on-Metal wear (1000s) Systematic Literature Review of 2318 publications we found 9 cases of cobaltism from CoM wear Periprosthetic Metallosis: Extreme Pseudotumors: Asymptomatic in several cases Hypercobaltemia: Extreme ppb Cobaltism: Deafness, Blindness, Dementia, Peripheral Neuropathy, Hypothyroidism, Cardiomyopathy

16 Metal-on-Metal wear (1,000,000) Systematic Literature Review of 2318 publications we found 25 cases of cobaltism from MoM wear Periprosthetic Metallosis: Moderate Pseudotumors: Common but sometimes asymptomatic Hypercobaltemia: Moderate to Severe ppb Cobaltism: Tinnitus, Disordered Mood and Sleep, Cognitive Dysfunction, Anorexia, Patchy Retinopathy, Cardiomyopathy

17 Taper Corrosion (3,000,000) Recently recognized cause of APRMD and Hypercobaltemia. Most hips done past 20 years at risk. Cobaltism yet to be reported. Periprosthetic Metallosis: Minimal Pseudotumors: Common but sometimes asymptomatic Hypercobaltemia: Minimal to Moderate < 1-20 ppb Cobaltism: Tinnitus, Disordered Mood and Sleep, Cognitive Dysfunction, Anorexia, Diastolic Dysfunction, common (Alaska)

18 Pseudotumor AKA APRMD Adverse Periprosthetic Reaction to Metallic Debris

19 Osteolysis, Pseudotumor, Sciatica Minimal Metallosis and Hypercobaltemia (0.9) 56 YO active male 6 years post THA Popular nonrecalled Stryker 32 mm MoP 510K hip No perceived problem with the hip Osteolysis detected with surveillance XR

20 Monitoring Hip Patients at Risk Blood Cobalt Level (PBB) 0.2 normal, > 1.0 excess exposure (Industry) 1 small ball Metal-on-Metal THA 2-3 large ball Metal-on-Metal HR or THA 2-10 APRMD, subclinical and mild cobaltism subclinical, mild, and moderate cobaltism moderate to severe cobaltism extreme manifestations, DEATH (1 case) Cobalt debris from corrosion more toxic at the hip and systemically than that from wear?

21 Cobaltism Awareness - December 2010 The report is unusual because of the rarity of the occurrence of metalinduced systemic complications in patients with total hip replacement and the fact that the author was one of the patients. As millions of patients worldwide have undergone total hip replacement, these cases represent rare events indeed.

22 Cobaltism Awareness January 2014 JBJS

23 Alaskan MoM Hip Series 35 revised of < 100 at risk Median [BCo] = 40 PPB 10 with reversible Cobaltism?Mean latency to illness 2 years Mean latency to revision 3 years Population at risk NOT systematically screened

24 Cobaltism: Severity relates to the degree and duration of cobaltemia literature review, wear cases.

25 Alaskan Rejuvenate Series Recalled Implant 30 revised of about 70 at risk Median [BCo] = 4 PPB 10 with reversible Cobaltism? Mean latency to illness 2 years Mean latency to revision 3 years Population at risk systematically screened

26 Alaskan Non-Rejuvenate Series Taper Corrosion Hips 6 revised of about 20,000 at risk Median [BCo] = 4 PPB 5 with reversible Cobaltism? Mean latency to illness 5 years Mean latency to revision 7 years Population at risk NOT systematically screened

27 Cobaltism Awareness: Systematic Monitoring of Patients with MoM Hips Indicated Young patient, missed 2 annual follow-ups but saw surgeon socially 1-2 times a week [BCo] = 63 ppb Reversible Neurocobaltism with K Device Not recalled months of surplus morbidity

28 Cobaltism Awareness: Severe Cobaltism may precede Hip Symptoms 510K Device Not recalled 46 y.o. Pilot F/H PD 2009 Biomet Magnum MoM Hips 42 months max DBS & Drugs Onset of hip pain B[Co] = 116 PPB Hips Revised to Ceramic-on-Plastic 2 months post revision B[Co] = months post-op off DBS & Drugs 2 years post-op off Drugs, min DBA

29 Cobaltism Awareness: Systematic Monitoring of Patients at Risk for Taper Corrosion Indicated Rejuvenate Implanted 8/ K RECAL L 20 months later: progressive fatigue, poor sleep, nausea, weight loss from 140 to120 pounds, deafness, myalgia, cognitive decline, arrythmia and diastolic dysfunction B[Co] = 11 PPB RECALLED 7/2012 (at 23 months) Explanted after 33 months

30 4 Million at Risk?! 56 yo male: 6 and 3 years s/p 32 mm CoCr-on-Plastic non-revujenate Styker Hips Several months left groin pain: [BCo] = 4 PPB Admitted to CCU post screening ECHO for acute asymptomatic proximal aortic dissection Popular 510K Not known to be AT RISK STRYKER ACCOLADE

31 CoCr-on-Plastic MOST POPULAR HIP USA Past 20 years 510K Device Zimmer MLT Stem 32 mm CoCr Head Longevity Socket Liner 66 year-old med-mal attorney 4 months of left groin pain 8 years post implant [BCo] of 4 PPB

32 Altered Stem-Head Tapers 510K

33 Cobaltism may precede Hip Symptoms Alaskan MoM Series

34 Extreme Hypercobaltemia and Cobaltism Not Rare in Patients Implanted with PMA HIP RESURFACING DEVICES Smith and Nephew BHR PREEMPTION PROTECTION Implanted for 36 Months Blood Cobalt Level 322 PPB Same as NEJM case that needed heart transplant

35 Patients with modular Chrome-Cobalt Components may require systematic monitoring of cobalt levels! Annual [BCo]: > 1 ppb is significant hypercobaltemia Cross-sectional imaging indicated any at risk patient with hip symptoms and for asymptomatic patients with B[Co] > 2.9 ppb Consider Revision [BCo] > 10 pbb Any systemic manifestations c/w cobaltism and B[Co] > 3 ppb Hip symptoms and pseudo-tumor

36 New Hips: Evolution More Stable Less Wear (mm) 3 Lasts longer no Saves bone - no Easier Revision-no Marketing or Science? Unexpected Toxicity

37 Proving Non-inferiority Of New Hips The Holy Hand Prospective 10 year Study of a thousand hips blinded with controls by uninvested Investigators Joint Registries Retrospective Grenade Comprehensive practice review with explant analysis

38 Tribology & Corrosion Unexpected Long Latency Significant

39 Summer 2010 Regulatory Response CDC Atlanta Let s Circulate this Nationwide FDA Washington DC No, medical devices our our turf Dr. Tower is not an expert FDA s Criteria for Expertise Industry Consultant or Furthered by Orthopedic Professional Organization

40 Primary Hips USA 270,000 per year $30,000 Basic $60,000 (Bells Whistles) 10 Billion $ a year 95% 510K unproven implants

41 Revision Hip Replacement USA 50,000 per year $50-100k each $2.5 Billion yearly

42 Metal-Metal hip surplus ten year costs: 10.6 Billion Dollars One Million MoM Implanted $5K increased primary implant costs Excess ten year revision rate 10-50% $60K revision cost 10% 5 year revision rate of revisions $ yearly serum monitoring costs

43 What went Wrong? Conflict of Interest? Premarket Market Regulation Professional spheres Post Market

44 Cost of Metal-Metal Debacle USA A Billion Dollars per year Design Surgeons of the ASR paid about $20 Million Cost of 510K Debacle USA? Ten Billion Dollars per year

45 Solutions An NTSB approach to premature total joint failures Regional registries that employ explant analysis to determine the probable cause of failures Identification of Canary in the Cage early sentinel implant failures Non-conflicted analysis of new technologies Regulatory reform mandating use of proven, less expensive implants for most all

46 Operational Budget $350,000 a year

47 Hip Replacement Costs USA 12K 120K JAMA 2/2013 Retrospective Study $ 0.01 per implant Implant Registration $50 per implant Efficacy Safety And Value Explant Analysis 1K per Explant Generic Parts 5K Revision surgery K Un-Proven parts 15K Space Suits 1K (increase infections 3X) Cost, Complexity, and Complications

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